Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure

June 10, 2025 updated by: Younan Ramsis, Ain Shams University

Efficacy of Intra-ureteric Aminophylline Instillation on Flexible Ureteroscopy Procedure: A Randomized Controlled Study

in this study we are going to evaluate the efficacy of intra-ureteric aminophylline instillation in facilitating ureteric access sheath placement prior to flexible ureteroscopy in reducing ureteric injury rates.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Urolithiasis (kidney and ureteral stones) is a common urologic condition with increasing prevalence. Flexible ureteroscopy (FURS) is a minimally invasive technique widely used for upper ureteric and renal stones. Aminophylline, a methylxanthine derivative, has been shown to relax smooth muscles and was previously used intravesically to facilitate rigid ureteroscopy with reduced complications. This study aims to assess whether intra-ureteric aminophylline instillation improves the ease of ureteral access sheath (UAS) placement during FURS and reduces ureteric injuries.

patients will be divided into 3 groups:

  1. Group A (Aminophylline Group): Intra-ureteric instillation of aminophylline
  2. Group B (Ureteral Dilator Group): Traditional ureteral dilators
  3. Group C (Combination Group): Aminophylline instillation + Ureteral dilators follow up of the patients will be through the success rate or failure of ureteric access sheath placement, operative time, bleeding, intra/postoperative complications and stone clearance (3-week follow-up with CT scan)

Study Type

Interventional

Enrollment (Estimated)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ali Khaled Mohammed Ali Dr. Ali Khaled, MSc.
  • Phone Number: +201099978174
  • Email: ali.khaled94@gmail.com

Study Contact Backup

Study Locations

  • Egypt
    • Abassia
      • CAiro, Abassia, Egypt, 11517
        • Recruiting
        • Ain Shams University Hospitals
        • Contact:
        • Contact:
          • Younan R. Lecturer Dr. Younan Ramsis Samir, PhD.
          • Phone Number: 201255511
        • Principal Investigator:
          • Younan R. Samir, PhD.
        • Principal Investigator:
          • Mahmoud A. Dr. Mahmoud Ahmed, PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Upper ureteric stones or renal stones < 2 cm

Exclusion Criteria:

  1. Ureteric strictures.
  2. anatomic renal disorders
  3. functional renal disorders
  4. Urinary tract infection.
  5. Coagulopathy and uncorrected bleeding disorders.
  6. Prior DJ stenting
  7. any contraindication for aminophylline use: (hypersensitivity to theophylline, ethylenediamine, or any component of the drug formulation, pregnancy or lactation, active peptic ulcer, presence of cardiologic diseases, presence of neurologic diseases, presence of renal impairment and presence of hepatic dysfunction)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Aminophylline Group: Intra-ureteric instillation of aminophylline
a ureteric catheter 6 Fr will be used for instillation of normal saline supplemented with aminophylline 250 mg/10 mL at three points (Pelvi-ureteric junction, upper sacroiliac joint level and proximal to uretero-vesical junction by 5 cm) then wait for 5 minutes
Drug: Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy
Intraureteric aminophylline installation prior to ureteric dilatation
Other Names:
  • Intraureteric Aminophylline instillation prior to access sheath insertion
Active Comparator: Group B: Ureteral Dilator Group: Traditional ureteral dilators
traditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr
Device: Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy
traditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr
Other Names:
  • ureteric teflon dilators prior to access sheath insertion
Other: Group C: Combination Group: Aminophylline instillation and Ureteral dilators
Aminophylline will be instilled as in group (A) then followed by traditional ureteral dilatation as in group (B)
Drug: Usage of Aminophylline prior to ureteric dilatation in Flexible uretroscopy
Intraureteric aminophylline installation prior to ureteric dilatation
Other Names:
  • Intraureteric Aminophylline instillation prior to access sheath insertion
Device: Sequential teflon dilator usage prior to ureteric access sheath placement in flexible uretroscopy
traditional ureteral dilators will be used. We will start by ureteral dilator 6 fr and gradually increase the size up to 12 Fr
Other Names:
  • ureteric teflon dilators prior to access sheath insertion
Other: Aminophylline instillation and Ureteral dilators together
Aminophylline will be instilled as in group (A) then followed by traditional ureteral dilatation as in group (B) prior to placing the ureteric access sheath
Other Names:
  • combination of aminophylline instillation and ureteric teflon dilators prior to access sheath insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The successful placement of ureteric access sheath
Time Frame: intraoperative application of the access sheath
we will assess the successful placement of ureteric access sheath in patients (that the access sheath is passed on the guide wire till the pelviureteric junction portion of the ureter after the usage of intraureteric aminophylline or teflon dilators or the usage of both.
intraoperative application of the access sheath

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
successful stone clearance
Time Frame: 3 weeks postoperative follow up with urinary tract multislice CT
the stone free rate following intervention
3 weeks postoperative follow up with urinary tract multislice CT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Younan Samir, PhD, Ain shams university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

February 17, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intraureteric aminophylline

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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